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Oral Azacitidine (CC-486) Epigenetic Priming and Maintenance for Adult Acute Myeloid Leukemia (AML) Patients

NCT06180863 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-12-26

No results posted yet for this study

Summary

To investigate the feasibility of delivering oral azacitidine (CC-486) as a consolidation regimen from the time of first complete remission (CR1), in patients with acute myelogenous leukemia (AML) eligible for curative intent Allogeneic Stem Cell Transplant (ASCT).

Conditions

Interventions

DRUG

oral azacitidine (CC-486)

Oral azacitidine is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Lohith Gowda, MD · Yale University

  • Marcos de Lima, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2028-11-30
Completion
2029-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180863 on ClinicalTrials.gov